The UK’s new medicines and medical devices regime – next steps

A Commissioner for Patient Safety

An important change in the Act, compared to the Bill as first proposed, is the addition of a Commissioner for Patient Safety. The twin objectives of this role are:

• promoting patient safety
• promoting the importance of the views of patients and members of the public

The Commissioner will be responsible for involving patients in its work, and will be able to require information from a wide range of public bodies and other service providers.  The Commissioner will not have the power to intervene in individual cases, although will be entitled to take these into account when reviewing broader issues.

Broad powers to amend and supplement existing regulation

As we have discussed previously, the Act brings in wide powers for the Health Secretary to amend and update existing regulations in relation to medicines and medical devices.

A change from the original draft sees the introduction of an overarching objective of safeguarding public health. This underlies the three aims of any regulatory change, namely:

• safety
• availability
• the UK offering a favourable environment for pre-clinical and clinical research, development, manufacture and supply

The Health Secretary is also required to carry out a risk-benefit analysis where any change might have an impact on safety.

The areas that can be addressed in amendments to human medicines regulation are wide-ranging, including the grant of marketing authorisations, import, distribution and supply, pharmacies, labelling and packaging, advertising, measures to prevent supply of falsified medicines, etc. It is worth noting that the use of tissues or cells in relation to human medicines is specifically called out in this list, which reflects the rising interest in regenerative medicine and the need for the regulatory environment to be flexible yet robust to support innovation in this area. The clinical trials regime can also be amended, with an option to introduce changes corresponding to the EU Clinical Trials Regulation that is yet to take effect.

The Health Secretary can also bring in updates to fees and enforcement rules, although there is an upper limit of two years where a criminal sentence of imprisonment is introduced.

Similar updating powers apply in relation to veterinary medicines, although with the overarching objectives of animal health and welfare, public health and safety and environmental protection.

International collaborations

A new section permits the disclosure of information between regulators where there is an international agreement or arrangement. This is constrained by patient confidentiality, commercial confidentiality and other restrictions such as data protection legislation.

Medical devices – an information centre and advisory committee

The Act introduces a framework for a Health and Social Care Information Centre intended to track and record information on medical devices. One of the problems highlighted by the Cumberlege Report was the absence of adequate recording systems, especially for higher risk devices. The planned Information Centre will be able to require registration of individual devices and introduce a unique identifier system for medical devices.

An advisory committee to support the Health Secretary in relation to medical device regulation will be set up.

Medical devices – enforcement

A key objective of the legislation was to consolidate and update enforcement provisions on medical devices. The current enforcement provisions are spread across several different pieces of legislation, including the Medical Devices Regulations 2002, the Consumer Protection Act 1987, the Consumer Rights Act 2015 and the General Product Safety Regulations 2005 - a confusing picture for both regulators and businesses.

The new regime will take medical devices out of the safety regulations provisions of the Consumer Protection Act regime altogether, and set up a specific system of civil and criminal sanctions for the medical devices market. These enforcement provisions are largely unchanged from the first draft of the Bill.

The Act introduces a specific offence for serious contraventions of the Medical Devices Regulations 2002, in addition to the offence for failure to comply with the notices set out in the next section below. These offences can lead to 51 weeks’ imprisonment.

A due diligence defence is available for a person accused of an offence.

Where an offence has been committed by a company, the Act provides a mechanism for punishment of those in senior positions. This includes requirements of either “consent or connivance”, or “attributable to neglect” of the individual, similar to the wording used in the legislation applicable to the pharmaceuticals, aviation and nuclear industries.

It also sets up a system of civil sanctions as an alternative to criminal prosecution. Under this system, the Health Secretary can impose monetary penalties where satisfied beyond reasonable doubt that a criminal offence has been committed. Schedule 2 sets out the mechanics for these penalties. A notice is served on the person said to be infringing the legislation. They can then make representations and bring an appeal before the First-tier Tribunal (part of the UK judicial system).

Notices

The Act introduces a series of notices that can be used to address differing levels of risk. These replace a similar set of notice provisions in the Medical Devices Regulations 2002, and are:

• Compliance notices – where the relevant authority has reasonable grounds to suspect that a person involved in marketing or supplying a medical device is not complying with a medical devices provision.
• Suspension notices – where the relevant authority considers that it may be necessary to restrict the availability of a medical device in order to protect health or safety.
• Safety notices – imposing prohibitions or requirements that the enforcement authority considers necessary to restrict the availability of a medical device in order to protect health or safety.
• Information notices – where the relevant authority considers that a person has information which the enforcement authority needs for the purpose of deciding whether to serve, vary or revoke the above notices.

The relevant authority for these purposes will normally be the MHRA, although the powers can be deployed by a local authority in relation to devices intended for consumer use.

It will be possible to appeal to the courts against service of these enforcement notices. Breach of a notice can lead to criminal sanctions.

Liability to those suffering harm

The Act provides that failures to comply with medical devices regulations amount to a breach of statutory duty. This gives a basis for action by people who may suffer harm – replacing a similar duty in the Consumer Protection Act.

Points to note

Much of the Act sets out new powers and structures to develop and update existing legislation on medicines, clinical trials and medical devices. We will follow these changes as they develop.

The reworking of the medical devices enforcement regime is helpful overall in that it brings together and tailors existing provisions that are spread around other pieces of legislation. However, there is some toughening up of the regime, with possible terms of imprisonment extending to 51 weeks.

The introduction of new roles and entities (the Commissioner for Patient Safety, the medical device Information Centre and advisory committee) will change the overall scheme and operation of regulation in this area, with patient safety and patient voice taking on a higher priority than either currently has.

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